NeoThelium FT for Open Wound

Overseen By Angelina Ferguson, DNP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NuScience Medical Biologics, LLC

Must not be taking: Immunosuppressants, Chemotherapy, Topical steroids, others

Disqualifiers: Diabetic foot, Pressure wound, Venous leg, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1-14 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new skin graft called NeoThelium FT to help heal open wounds. Researchers aim to determine if this treatment is safe and effective for wounds open for at least four weeks. The process involves cleaning the wound, applying the skin graft, and using dressings to maintain moisture. Individuals with a chronic open wound that is not infected and measures between 1 and 25 cm² may qualify for this study. As an unphased trial, this study provides a unique opportunity to contribute to medical research and potentially benefit from an innovative treatment.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on immunosuppressants, chemotherapy, or topical steroids, you may need to stop them before joining the trial.

What prior data suggests that NeoThelium FT is safe for open wound management?

Research has shown that NeoThelium FT underwent safety testing in earlier studies. So far, patients have tolerated it well, with no reports of serious side effects. While some mild side effects might occur, nothing severe has been observed.

NeoThelium FT is under study for its potential to heal open wounds. It employs an amnion skin graft, a type of tissue previously used in medical treatments, suggesting its safety. Overall, the available data supports that NeoThelium FT is generally safe for use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

NeoThelium FT is unique because it combines traditional wound care with an innovative component designed to enhance healing. Unlike standard treatments that often focus solely on cleaning and dressing wounds, NeoThelium FT integrates an advanced application method that aims to optimize moisture balance and promote faster tissue recovery. Researchers are excited about this treatment because it not only includes essential steps like cleansing and debridement but also introduces a new approach to offloading, which could lead to improved healing outcomes and reduced recovery times for patients with open wounds.

What evidence suggests that NeoThelium FT is effective for open wounds?

Research has shown that NeoThelium FT, administered alongside standard of care (SOC) in this trial, may aid in treating chronic open wounds. In earlier studies, patients with wounds that showed little improvement over 14 days experienced better healing with NeoThelium FT. This treatment employs a special skin graft that maintains moisture in the wound, promoting healing. Early results suggest that wounds treated with NeoThelium FT heal more effectively than untreated ones. These findings position NeoThelium FT as a promising option for managing difficult-to-heal wounds. ^{1 3 5 6 7}

Who Is on the Research Team?

Angelina Ferguson, DNP

Principal Investigator

SygNola, LLC

Are You a Good Fit for This Trial?

Adults 18+ with chronic open wounds present for over 4 weeks, without infection or exposed bone. They must have adequate circulation in the affected limb and a wound size between 1-25 cm2 and less than 1cm deep. Excluded are those with serious health issues, sensitivity to amniotic products, pregnant/breastfeeding women, cancer patients, or anyone on certain medications that affect healing.

Inclusion Criteria

Subject is able and willing to follow the protocol requirements

Subject had signed informed consent

I have had an open wound for more than 4 weeks.

Exclusion Criteria

Subject is unable to comply with protocol treatment

Subject has major uncontrolled medical disorders in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders that may affect wound healing

Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly applications of NeoThelium FT Amnion Skin Graft along with standard of care (SOC) for wound management

1-14 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for wound closure and maintenance during the follow-up period

2 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• NeoThelium FT

Trial Overview The trial is testing NeoThelium FT Amnion Skin Graft's effectiveness and safety in treating open wounds. Participants will receive this grafting treatment while their progress is monitored to see how well the wound heals compared to before treatment.

How Is the Trial Designed?

Group I: NeoThelium FT + SOC Experimental Treatment 1 Intervention

Wound cleansing, sharps debridement, NeoThelium FT application, Dressing for moisture balance, Offloading

Who Is Running the Clinical Trial?

NuScience Medical Biologics, LLC

Lead Sponsor

SygNola, LLC

Industry Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06918561

Evaluating the Efficacy of NeoThelium FT in the Treatment ... Subject has a chronic open wound with a historical wound measurement showing less than 25% healing within 14 days prior to screening; Subject has a chronic open ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06918548

Evaluating the Efficacy of NeoThelium FT in the Treatment ... Subject has a Pressure Injury/Ulcer with screening wound measurement showing less than 25% healing within 14 days prior to randomization. Subject has a ...

3. trialx.com trialx.com/clinical-trials/listings/325366/evaluating-the-efficacy-of-neothelium-ft-in-the-treatment-of-chronic-open-wounds/

Evaluating the Efficacy of NeoThelium FT in the Treatment ... Subject has a chronic open wound with a historical wound measurement showing less than 25% healing within 14 days prior to screening; Subject ...

4. trial.medpath.com trial.medpath.com/clinical-trial/bb47683588d9c8c0/nct07041177-neothelium-ft-amnion-graft-chronic-wounds

Prospective Case Series Evaluating the Efficacy and Safety of ... This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Open Wounds.

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06918561/evaluating-the-efficacy-of-neothelium-ft-in-the-treatment-of-chronic-open-wounds?dt_type=updated&state=LA&city=Slidell

Evaluating the Efficacy of NeoThelium FT in the Treatment ... Subject has a chronic open wound with a historical wound measurement showing lessthan 25% healing within 14 days prior to screening. Subject has ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07158658

Prospective Case Series Evaluating the Efficacy and Safety ... Study Overview. Brief Summary. This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of ...

7. withpower.com withpower.com/trial/phase-open-wound-7-2025-cafcd

NeoThelium FT for Open Wound Trial Overview The trial is testing NeoThelium FT Amnion Skin Graft's effectiveness and safety in treating open wounds. Participants will receive this grafting ...